George M Ghobrial1, William F Lavelle2, Jeffrey E Florman3, K Daniel Riew4, Allan D Levi1. 1. Department of Neurological Surgery and the Miami Project to Cure Paralysis, University of Miami Miller School of Medicine/Jackson Memorial Hospital, Miami, Florida. 2. Department of Orth-opedic Surgery, SUNY Upstate Medical University, Syracuse, New York. 3. Maine Medical Center Neuroscience Institute, Scarborough, Maine. 4. Department of Orthopedic Surgery, Columbia University Medical Center, New York, New York.
Abstract
BACKGROUND: Ten-year follow-up data from the US Food and Drug Administration investigational device exemption trial comparing BRYAN® Cervical Disc (Medtronic, Dublin, Ireland) arthroplasty to anterior cervical discectomy and fusion (ACDF) demonstrated that disc arthroplasty maintained range of motion and improvements in overall success and neck disability. OBJECTIVE: To compare the 10-yr rates of symptomatic adjacent level disease requiring surgery (SALDRS). METHODS: Prospective randomized trial data were analyzed comparing BRYAN® Cervical Disc arthroplasty to ACDF for single-level cervical disc disease with concordant radiculopathy or myelopathy with clinicoradiographic analysis at 10 yr. Secondarily, 84-mo data were pooled with PRESTIGE® Cervical Disc arthroplasty (Medtronic) study data to provide overall rates of SALDRS. RESULTS: Significantly greater overall success was maintained at every postoperative interval with an overall success rate of 81.3% with BRYAN® disc and 66.3% with ACDF (P = .005) without loss of motion preservation (8.69° vs 0.60°). Reoperation at adjacent levels up to the 120-mo visit was 9.7% in the arthroplasty group and 15.8% in the ACDF group (P = .146). The combined data from BRYAN® and Prestige ST demonstrate that BRYAN® and Prestige disc groups had a lower rate of second surgeries at the adjacent levels, up to the 84-mo visit, compared to the combined ACDF groups (6.9% vs 11.7%; P = .023). CONCLUSION: Compared with ACDF, fewer patients with the BRYAN® disc required surgery for symptomatic adjacent level degeneration, but this did not achieve statistical significance. Analysis of combined study data using Bryan and Prestige discs shows significant differences in SADLRS as early as 7 yr.
RCT Entities:
BACKGROUND: Ten-year follow-up data from the US Food and Drug Administration investigational device exemption trial comparing BRYAN® Cervical Disc (Medtronic, Dublin, Ireland) arthroplasty to anterior cervical discectomy and fusion (ACDF) demonstrated that disc arthroplasty maintained range of motion and improvements in overall success and neck disability. OBJECTIVE: To compare the 10-yr rates of symptomatic adjacent level disease requiring surgery (SALDRS). METHODS: Prospective randomized trial data were analyzed comparing BRYAN® Cervical Disc arthroplasty to ACDF for single-level cervical disc disease with concordant radiculopathy or myelopathy with clinicoradiographic analysis at 10 yr. Secondarily, 84-mo data were pooled with PRESTIGE® Cervical Disc arthroplasty (Medtronic) study data to provide overall rates of SALDRS. RESULTS: Significantly greater overall success was maintained at every postoperative interval with an overall success rate of 81.3% with BRYAN® disc and 66.3% with ACDF (P = .005) without loss of motion preservation (8.69° vs 0.60°). Reoperation at adjacent levels up to the 120-mo visit was 9.7% in the arthroplasty group and 15.8% in the ACDF group (P = .146). The combined data from BRYAN® and Prestige ST demonstrate that BRYAN® and Prestige disc groups had a lower rate of second surgeries at the adjacent levels, up to the 84-mo visit, compared to the combined ACDF groups (6.9% vs 11.7%; P = .023). CONCLUSION: Compared with ACDF, fewer patients with the BRYAN® disc required surgery for symptomatic adjacent level degeneration, but this did not achieve statistical significance. Analysis of combined study data using Bryan and Prestige discs shows significant differences in SADLRS as early as 7 yr.
Authors: Melvin C Makhni; Joseph A Osorio; Paul J Park; Joseph M Lombardi; Kiehyun Daniel Riew Journal: Int Orthop Date: 2018-12-05 Impact factor: 3.075
Authors: Pierce D Nunley; Eubulus J Kerr; David A Cavanaugh; Phillip Andrew Utter; Peter G Campbell; Rishi Wadhwa; Kelly A Frank; Kyle E Marshall; Marcus B Stone Journal: Int J Spine Surg Date: 2020-06-30